A Phase 3 interventional study of CoronaVac and Placebo in COVID-19, sponsored by Health Institutes of Turkey. Completed at 25 sites in Turkey. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Health Institutes of Turkey · Phase 3, Interventional, and Prevention
This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18\~59 Years.
This study is a randomized, double-blinded, multi-center, placebo-controlled phase III clinical trial in adults aged 18\~59 years. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 13.000 subjects will be enrolled. Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14. It is planned that the study will be conducted with two separate cohorts. The first cohort will be healthcare workers in the high risk group (K-1) and the second cohort will be people at normal risk (K-2). After 2 doses of vaccination of 1300 volunteers are completed, safety data will be evaluated by the data safety monitoring board without breaking the blinding, and if there is no safety issue, the K2 cohort will continue to be vaccinated.1.300 volunteers, including 650 volunteers SARS-CoV-2 vaccine and placebo arms, will be included in the K-1 cohort. In the K-2 cohort (normal risk group for COVID-19), 7.650 volunteers were planned to be included in the SARS-CoV-2 vaccine group, and 3.500 volunteers in the placebo group.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 10,214 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Health Institutes of Turkey is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
600 SU of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 14 days apart.
Biological: CoronaVac
Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, intramuscular injection, two doses given 14 days apart.
Biological: Placebo
Two doses at 14-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (each prefilled syringe of the vaccine contains 600 SU of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,14
Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, two doses given 14 days apart.
Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19
Time frame: 2 weeks after the second dose of vaccination
Protection Indexes of One Vaccine Dose For Symptomatic COVID-19
The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination.
Time frame: 2 weeks after the second dose of vaccination
Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination
Time frame: 2 weeks after the second dose of vaccination
Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection
The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination
Time frame: 2 weeks after the second dose of vaccination
Safety indexes of adverse reactions in 28 days
The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination.
Time frame: 28 days after the second dose of vaccination
Safety indexes of adverse reactions in 7 days
The incidence of adverse reactions within 7 days after each dose of vaccination
Time frame: 7 days after each dose of vaccination
Safety indexes of serious adverse events in 1 year
The incidence of SAEs from the first vaccination to one year after the second dose vaccination
Time frame: 1 year after second dose of vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 14 days
The seroconversion rate, seropositivity rate 14 days after each dose vaccination
Time frame: 14 days after each dose vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days
The seroconversion rate, seropositive rate 28 days after the second dose vaccination
Time frame: 28 days after the second dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 14 days
GMT and GMI of neutralizing antibody and IgG 14 days after each dose vaccination
Time frame: 14 days after each dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 28 days
GMT and GMI of neutralizing antibody and IgG 28 days after the second dose vaccination
Time frame: 28 days after the second dose vaccination
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Health Institutes of Turkey